Challenge
A multinational oral-care leader required robust toxicological substantiation for a dual-active toothpaste to support anticavity and sensitivity-safe claims and achieve FDA (OTC Monograph) and MoCRA compliance.
Approach
Comprehensive toxicological risk assessment (ingredient-level, exposure-based)
Prop 65 screening for U.S. compliance
Review of FDA OTC Monograph alignment for active ingredients
Development of MoCRA safety substantiation framework
Outcome
Achieved regulatory-ready safety documentation for U.S. and EU markets
Enabled confident product positioning with substantiated safety claims
Strengthened audit readiness and compliance framework
Impact
- 0 regulatory observations
- Approved across multiple key markets (USA | Europe)
- Enhanced consumer trust through science-backed safety
Transformation
Before: Limited toxicological substantiation for dual-active claims and evolving FDA/MoCRA requirements
After: Robust, audit-ready safety framework supporting compliant claims and multi-market approval
From claims to compliance - delivering confidence through science.